Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors

Phase 1

Completed

• Conditions: Triple-Negative Breast Cancer; High-grade Serous Ovarian Cancer; Solid Tumors; NUT Midline Carcinoma
• Interventions: Drug: CUDC-907

• Registration Number: NCT02307240
• Lead Sponsor: Curis, Inc.

Brief Summary

This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors.

Detailed Description

This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors. The following dosing schedule, consisting of 21-day treatment cycles, is being examined:

Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-04
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-30
• Last Update Posted: 2019-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

1. Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT rearrangement. subjects may be ≥16 years of age.
2. Histopathologically confirmed diagnosis of an advanced solid tumor such as breast cancer or midline carcinoma with NUT rearrangement, that has progressed despite standard therapy, or for which no standard therapy exists. For enrollment in the expansion cohorts, histopathological confirmation of triple-negative breast cancer or high-grade serous ovarian cancer is required.
3. Measurable or evaluable disease.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia).

Exclusion Criteria

1. Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin C within six weeks.
2. Radiotherapy within one week prior to starting study treatment.
3. Other investigational agent(s) within 21 days prior starting to study treatment.
4. Symptomatic central nervous system (CNS) involvement or lymphangitic metastasis. Stable or improving CNS disease that is not under active treatment after receipt of adequate therapy is allowed.
5. Uncontrolled or severe cardiovascular disease, including myocardial infarction or unstable angina within six months prior to study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease or cardiac amyloidosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CUDC-907 - five days on/two days off	CUDC-907	60 mg/day CUDC-907, oral administration, five days on/two days off until disease progression or other discontinuation criteria are met.

Primary Outcome Measures

Name	Time	Method
To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors	21 day cycle

Secondary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC).	21 day cycle
To assess the preliminary anti-cancer activity of CUDC-907	24 months	The Investigator will evaluate each subject for response to therapy according to standard response criteria for each individual subject's tumor type
To evaluate biomarkers of CUDC-907 activity	24 months

Trial Locations

Locations (4)

UCSF School of Medicine; 🇺🇸 San Francisco, California, United States

Florida Cancer Specialists; 🇺🇸 Sarasota, Florida, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States